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06. August 2010

EUROPEAN COURT OF JUSTICE

Protection conferred by DNA

In its recent decision C-428/08 of July 6, 2010, the European Court of Justice (ECJ) ruled on the scope of protection conferred by a patent claiming DNA sequences on the basis of Directive 98/44/EC of the European Parliament and of the Council, dated July 6, 1998, on the legal protection of biotechnology inventions (hereinafter the Biotechnology Directive). The Biotechnology Directive is binding for the EU member states with regard to the patentability of inventions in the field of biotechnology and the interpretation of national laws. Adherence to the Biotechnology Directive is regulated by ECJ.

In particular, the Biotechnology Directive stipulates that a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. As a consequence, a patent is only granted on an application claiming a DNA sequence if the function of the DNA sequence is indicated in the patent application. According to German patent law, said function has to be included in the claims. In contrast, the European Patent Convention (EPC) merely requires the inclusion of said function in the description of the patent application, if the DNA sequence per se is novel and inventive.

In the decision C-428/08, the ECJ now holds that said function also limits the scope of protection conferred to a patent claiming a DNA sequence. In particular, a product containing a patented DNA sequence, wherein the DNA sequence does not fulfil the specified function, does not fall within the scope of protection defined by the patent. In the case underlying the above decision Monsanto holds a patent in Europe for a DNA sequence which provides a soya plant with a herbicide resistance upon introduction. In the above decision, the ECJ stipulated that a soy meal imported into Europe containing traces of the patented DNA does not infringe the Monsanto’s patent, since the DNA does not provide herbicide resistance to the soy meal. Additionally, the ECJ made clear that the above Directive precludes the national patent legislation from offering absolute protection to a patented DNA sequence as such.


Therefore, in the decision C-428/08, the ECJ ruled that in terms of DNA sequences, a patent provides a purpose-limited product protection. In the case of a European Patent, wherein the limiting purpose can only be found in the description, an accurate examination / interpretation of the wording of the description of a European patent application seems therefore to be absolutely necessary, for determining the scope of protection of a European patent.

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